Drugplain

Publix .05 g/100mL

oxymetazoline hydrochloride · SPRAY · PUBLIX SUPER MARKETS, INC

10 Recalls on Record
Plain English

Publix is a spray containing oxymetazoline hydrochloride at .05 g/100mL, taken nasal. Manufactured by PUBLIX SUPER MARKETS, INC.

Key Facts

Brand Name
Publix
Generic Name
oxymetazoline hydrochloride
NDC Code (Product)
41415-716
Manufacturer
PUBLIX SUPER MARKETS, INC
Strength
.05 g/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
05/16/2019

Recall History

10 Recalls on Record
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II02/09/2023

L. Perrigo Company

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II10/19/2018

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue41,325 reports
nausea34,759 reports
dyspnoea34,304 reports
diarrhoea33,551 reports
drug ineffective32,169 reports
off label use31,212 reports
dizziness27,139 reports
headache26,243 reports
pain25,850 reports
asthenia23,352 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USES relieves occasional constipation to help restore and maintain regularity this product generally produces bowel movement in 12 to 72 hours

Dosage & Administration

DIRECTIONS take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning). this product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. Age Recommended dose Daily maximum adults & children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician

Warnings

Choking Warning: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea, or vomiting a sudden change in bowel habits that persists over a period of 2 weeks Ask your doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work. When using this product do not use for more than 7 days unless directed by a doctor do not take more than 8 tablets in a 24 hour period unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Frequently Asked Questions

What is Publix used for?

Publix contains oxymetazoline hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is Publix a controlled substance?

Publix is not classified as a controlled substance by the DEA.

What is the generic name for Publix?

The generic name for Publix is oxymetazoline hydrochloride. There are 12 other brand versions of oxymetazoline hydrochloride.

What is the NDC code for Publix .05 g/100mL?

The NDC (National Drug Code) for Publix .05 g/100mL is 41415-716, listed by PUBLIX SUPER MARKETS, INC.